Tele-Exercise and Multiple Sclerosis

NCT03117881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 911

Last updated 2024-12-11

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to compare the effects of two delivery models of an evidence-based complementary alternative medicine (CAM) program that combines neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with multiple sclerosis (MS). CAM will be delivered as a 12-week program through two different delivery forms: On-site at a clinic (DirectCAM) and telerehabilitation (TeleCAM). Participants will be randomly assigned to one of these two groups.

\*\*On March 16th, 2020, the University of Alabama at Birmingham halted all onsite non-essential research in response to the Covid-19 pandemic. Since then, the study has begun to conduct all testing remotely through videoconferencing technology. In addition, another study group, remote DirectCAM (rDirectCAM), has been incorporated into the study to continue the 12-week program delivery for newly recruited participants via videoconferencing technology.\*\*

Conditions

Interventions

BEHAVIORAL

DirectCAM

The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.

BEHAVIORAL

TeleCAM

The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.

BEHAVIORAL

rDirectCAM

The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • Alabama Neurology Associates, PC

    collaborator OTHER
  • Lakeshore Foundation

    collaborator OTHER
  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2021-10-30
Completion
2022-10-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03117881 on ClinicalTrials.gov